The Food and Drug Administration floated the increase as part of its recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act. The law allows the FDA to charge fees for reviewing medical devices seeking federal approval. It will expire Sept. 30 unless reauthorized by Congress.
The FDA said it needs the fees to allow its device review program to keep pace with both the rapidly growing medical device industry and changes in technology.The agency proposes collecting 31 percent more in fees next year, and then 8.5 percent more each year thereafter through 2012. The $287 million in industry fees collected during that five-year period would account for only about 23 percent of the more than $1.2 billion the FDA estimates it will need to spend on reviewing medical devices during that period. Taxpayer funding would make up the balance.
In negotiating the fees, companies exact pledges from the FDA, including faster and more predictable review times for their devices.
“Innovation in the medical technology industry is rapid, and this user fee agreement will provide FDA the resources it needs to prepare for the coming wave of 21st century medical technology,” said Stephen Ubl, president and chief executive officer of AdvaMed, a medical device industry group.
The FDA assesses pharmaceutical companies fees to review new drugs as well. Critics of the FDA’s growing reliance on industry-paid fees allege they give industry undue influence over the approval process _ a charge the agency denies.
The FDA will accept public comments on the proposal for the next 30 days. It plans a public meeting on April 30.
On the Net:
Food and Drug Administration medical device fees:„http://www.fda.gov/cdrh/mdufma/„